Pegclear Jar

Polyethylene Glycol 3350 Powder for Oral Solution

Composition:

Each 8.5 g (one measuring spoonful) contains:

Polyethylene Glycol 3350 USP-NF……………8.5 g

Dosage Form: Powder for Oral Solution

Dosage Strength: 8.5 g per one measuring spoonful

4.1 Therapeutic indication

For the treatment of occasional constipation.

This product should be used for 2 weeks or less or as directed by a physician.

4.2 Posology and method of administration

Dosage:

Adults: The usual dose is 17 grams (2 scoops) of powder per day. Take 2 scoops of powder & add water to make it to the mark of 125 ml/dose. It can be taken 1 to 3 times per day according to individual response.

Pediatrics:

Children 2 - 6 years - Take 1 scoop of Powder & add water to make it to the mark of 62.5 ml/dose.

Children 6 years & above - Take 2 scoops of Powder & add water to make it to the mark of 125 ml/dose. Dose should be adjusted up or down as required to produce regular soft stools. The maximum dose does not normally exceed 3 scoops per day for both pediatric age groups.

Directions for use:

Each Peclear^TM Jar is supplied with a measuring spoon to contain 8.5 grams of laxative powder when filled. Water/milk/fresh Juice can be used to dissolve the powder. Stir briskly and consume the contents immediately. 1 to 3 days may be required to produce a bowel movement.

4.3 Contraindications

Pegclear Powder for Oral Solution is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

4.4 Special warnings and precautions for use

Warnings

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Pegclear^TM therapy.

Precautions

General: Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid Intake, regular exercise) which may produce more regular bowel habits.

Laboratory Tests: No clinically significant effect on laboratory tests have been demonstrated.

4.5 Drug interactions

No specific drug Interactions have been demonstrated.

4.6 Use in special populations

Pregnancy:

There are limited amount of data from the use of Pegclear^TM in pregnant women. Studies in animals have shown indirect reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to polyethylene glycol 3350 is negligible. Pegclear^TM can be used during pregnancy.

Lactation:

As systemic exposure of the breast-feeding woman to PEG 3350 is negligible, no effects on the breastfed newborn/infant are anticipated, and PEG 3350 can be used during breast-feeding.

Geriatric Use:

There is no evidence for special considerations when Pegclear^TM is administered to elderly patients. In geriatric nursing home patients, a higher incidence of diarrhea occurred at the recommended 17 g dose. If diarrhea occurs Pegclear^TM should be discontinued.

4.7 Effects on ability to drive and use machines

Polyethylene Glycol 3350 Powder for Oral Solution has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients.

Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. Severe pain or distension, diarrhoea, vomiting may occur in case of overdosage. Medication should be terminated and free water administered. Severe pain or distention can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

The oral LD50 Is >50 gm/kg in mice, rats and rabbits.

5.1 Mechanism of Action

Pharmacotherapeutic group: osmotically acting laxative.

Polyethylene glycol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. PEG 3350 increases the stool volume, triggering the colon motility via neuromuscular pathways leading to an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation.

5.2 Pharmacodynamic properties

Pharmacodynamic effect of PEG 3350 as a laxative is primarily due to its osmotic action, which increases water content in the stool, softens it, and facilitates easier passage of stool, thereby relieving constipation. In clinical studies an increase in frequency bowel movement and daily stool weight was observed.

In vitro study showed indirectly that PEG 3350 was not fermented into hydrogen or methane by the colonic microflora in human feces. PEG 3350 appears to have no effect on the active absorption or secretion of glucose or electrolytes. There is no evidence of tachyphylaxis.

6.1 Animal Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term carcinogenicity studies, genetic toxicity studies and reproductive toxicity studies in animal have not been performed with Pegclear^TM.

PEG 3350 is an osmotic agent for the treatment of constipation.

PegclearTM (polyethylene glycol 3350, NF) is a synthetic polyglycol having an average molecular weight of 3950.

The chemical formula is HO(C₂H₂O)nH in which n represents the average number of oxyethylene groups.

Below 55°C it is a free flowing white powder freely soluble in water.

8.1 Incompatibilities

None applicable

8.2 Shelf-life

Refer on pack.

8.3 Packaging information

Pegclear^TM Jar contains 119 g of PEG 3350 Powder for Oral Solution

8.4 Storage and handing instructions

Store in a dry place below 25°C.

Protect from light and moisture.

Keep out of reach of children.

• PEG 3350 softens the stool and Increases the frequency of bowel movements by retaining water in the stool.
• It should always be taken by mouth after being dissolved in Water/milk/fresh Juice. Should unusual cramps, bloating, or diarrhea occur, consult your physician.
• 1 to 3 days may be required to produce a bowel movement.
• This product should be used for 2 weeks or less or as directed by a physician.
• Prolonged, frequent or excessive use of PEG 3350 may result in electrolyte Imbalance and dependence on laxatives.

28th June 2024